Stress Hormones and IUDs
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03499379|
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment|
|Contraception Mood Change||Device: Mirena Device: Paraguard|
|Study Type :||Observational|
|Actual Enrollment :||39 participants|
|Official Title:||Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration|
|Actual Study Start Date :||April 16, 2018|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
Women initiating use of an intrauterine device
Women obtaining a copper or hormonal intrauterine device for the purpose of contraception.
A hair sample of approximately 10 (up to 20) hairs cut close to the scalp of the posterior vertex will be taken at the time of IUD insertion, 6 months post-insertion, and 12 months post-insertion.
A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
Other Name: levonorgestrel intrauterine system
A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
Other Name: Copper T380A IUD
- Mean change in hair cortisol concentration - 6 months [ Time Frame: Baseline & 6 months post-insertion ]A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 6 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 6 months.
- Mean change in hair cortisol concentration - 12 months [ Time Frame: Baseline & 12 months post-insertion ]A hair sample of approximately 10 (up to 20) hairs cut close to the scalp 12 months after start of study participation (baseline - IUD insertion) to assess change from baseline to 12 months.
Biospecimen Retention: Samples With DNA
A hair sample of approximately 10 (up to 20) hairs cut close to the scalp of the posterior vertex.
Whole blood samples collected at each study visit (approximately 10mL). The serum from those samples will tested for hormone levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499379
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Nora Doty, MD||Oregon Health and Science University|